Nyheter & Events

In this issue:

• Automation Today - Life Sciences Special Edition
• Ingredients for success
• ProsCon acquisition adds process knowledge and boosts expertise
• Meeting performance and quality goals
• Extended capabilities for Life Sciences Manufacturing Execution System
• Pharmaceutical giant aims to improve clinical trial supply chain
• Cutting-edge batch production
• Packaging pharmaceutical products: at Imanpack the care is clear to see
• Raising overall equipment effectiveness (OEE)
• Enterprise-wide visibility: the future is within your reach
• Streamlining production processes with MES
• Managing energy costs
• Pharma Automation
• Pharma MES

Electronic batch recording: the path to paperless production

Life Sciences industries are facing a fast-changing environment of regulatory pressure and societal expectations for personalised treatment, compounded by demands from investors and shareholders. Ensuring competitiveness in this climate through decreasing time to market (achieved by optimising the pipeline from R&D to manufacture) will be critical to ongoing success and even survival.

Targeted treatment solutions are the next evolutionary step in pharmaceutical development, and these require the transformation of industrial processes. Within many Life Sciences organisations the manufacturing function operates at a level well below its potential. Significant productivity and efficiency gains can routinely be delivered through intelligent utilisation of automation solutions to optimise processes and ensure quality, compliance and performance. The winners in tomorrow’s biotechnology and pharmaceutical marketplace will be those who embrace and reap the benefits of new manufacturing technologies and solutions.

One solution with the potential to revolutionise manufacturing flexibility, efficiency and productivity is Electronic Batch Recording (EBR). Real-time batch release, where all relevant process and product quality data are collected and analysed against specifications and then used to automate the batch release processes, is the vision that EBR realises.
EBR enables speeding up of the production cycle and reduces inventory through faster batch release.

EBR is more than a direct transfer of paper-based processes onto ‘glass’. As an operator tool, it reduces complexity in standard operating procedures (SOPs) by eliminating steps and replacing these with fewer executables. As a management tool, it is key to linking essential manufacturing information from the production line into automation and ERP systems. Finally, in the review and validation cycle, it has great potential as a key driver in transforming efficiency of manufacturing in the Life Sciences industries.

EBR introduces a fundamentally different method of review and validation. ‘Review by exception’ is a much improved alternative to the traditional review of all batch results, requiring production to be halted only for verification (for example to add an electronic signature or to assess deviation in the batch that is outside of pre-set parameters and tolerances). By re-engineering the long-held batch review procedure, EBR is able to build quality, control and efficiency into the production process.
Factory-wide dataflow
EBR not only provides an electronic documentation system for review and validation, it also enables workflow definition and, more importantly, integration of a single, comprehensive electronic document with the MES and other software layers and applications across a number of platforms.
Automated and human interface data is acquired from hundreds of seperate sources throughout the production cycle, which the EBR combines within a single, easily transferable record. Electronic recording also enables closed-loop control of processes through return of information to the system to close the incident or execution. Similarly, EBR completes the data path from manufacturing back to R&D.
There are, of course, challenges in migrating from a paper-based process to EBR. In the transfer of process steps from the physical to the virtual world, fewer steps are necessary and executables eliminate layers of complexity. However, it is important to maintain re-usability in process definition. To ensure optimal implementation of EBR, some re-engineering of paper-based tickets will be necessary.
Compliance with FDA regulations (such as 21 CFR, part 11), local authorities and e-signature protocols in batch recording, as well as compliant electronic archiving (for example to ensure audit trail and version control) are also important requirements.

To maintain the EBR system, carefully defined nomenclature is essential. This will ensure low complexity of the master batch records and implementation of standard, and repeatable steps across all processes and all sites. Systematic nomenclature is also critical for storage, search, referencing and archiving of EBR, and it is the only way for scientists to select relevant data for further analysis.
EBR is an essential element for Life Sciences companies to support the Process Analytical Technology (PAT) paradigm and enable integrated, automated and compliant manufacturing environment that is required for future productivity gains and improved volume output.
EBR not only eliminates paper systems to better support compliance, it also optimises process, empowers versioning of master batch record procedures, and establishes a platform for undertaking more complicated manufacturing operations.
There are many benefits to utilising a well-designed Electronic Batch Recording system: documentation errors are reduced, missing entries are eliminated altogether, and adverse results are reported immediately. Each of these components helps to mitigate the risk of non-compliance. Efficiency is the other major benefit of automating the batch recording procedure. Reduced review times lower operational cost, shorten production cycle time and increase product throughput, thereby improving delivery performance and profitability.

Competitive advantage and sustainable efficiency in manufacturing is the prize available to all adopters of integrated information and automation solutions. Electronic Batch Recording is a catalyst for change; those companies who are able to recognise its potential to transform manufacturing in the Life Sciences industries will be the winners in the demand-driven marketplace of tomorrow.

For more information, please e-mail us at: info_at@ra.rockwell.com with ref: EBR